In future medicine, it is indispensable to solve medical problems in the aged society. One of the problems of such medicine for the aged is great difficulty for patients with advanced age in taking any of the currently used dosage forms of medical compositions for oral administration. Patients with dysphagia have also been suffering from this problem that it is difficult to take a medical composition for oral administration.
For example, the medical compositions for oral administration listed in the general medical preparations of Japanese Pharmacopoeia include tablets, capsules, pills, powders, liquid, syrup, and the like. Such dosage forms are not easily taken by patients of advanced age, particularly patients with dysphagia. Among these, liquid and syrup preparations are easily taken by them as compared with the other dosage forms. However, because of liquid, there are problems to be overcome, when formulating into dosage forms, such as masking of bitterness of effective components, their dispersibility and stability. Particularly, patients with dysphagia cannot take such a medical composition because they are choked by water. Ito et al. (Monthly Pharmaceutical, Vol. 37, No. 11, p 45-49 (1995)) reported that patients with advanced age cannot easily take tablets or capsules depending on their sizes. Thus, it has been desired to develop new pharmaceutical preparations that are easily taken by patients of advanced age or patients with dysphagia.
In order to solve the above problems for patients of advanced age, Ito et al. proposed to use liquid preparations having high viscosity as one of the medical preparations for them (Monthly Pharmaceutical, Vol. 37, No. 11, p 45-49 (1995)). Another report (Clinical Nutrition, Vol. 79, No. 1, p 22-39 (1991)) describes that liquid preparations having high viscosity are favorably used as one of the dosage forms of medical preparations that can be easily taken by patients with dysphagia. Thus, from general viewpoints, it has been considered that liquid preparations having high viscosity are appropriate as a dosage form of medical preparations for oral administration that can be easily taken by patients of advanced age and patients with dysphagia.
Actually for clinical use for, it was reported that, as nosocomial medicines, a highly viscous liquid pharmaceutical preparation was prepared usually using one or two or more of gelatin, pectin, xanthan gum, carrageenan, and the like upon use or with the short applicable term to administer it to patients who could not easily take usually used medical preparations for oral administration (Medical Care and New Drugs, Vol. 13, No. 11, p 208-214 (1994), Pharmacy, Vol. 42, No. 11, p 53-59 (1991)). However, even the above-described highly viscous liquid pharmaceutical preparations are still unsatisfactory in easiness to take. Further, these preparations are used only for a limited period of short time since it is difficult to secure their long-term stability. In other words, there are such problems that the viscous pharmaceutical preparations cannot keep viscosity to become an aqueous state, that their original appearances are difficult to maintain, and that their preservation stability including maintenance of the contents of the effective components is not sufficient. Accordingly, it has been desired to develop a medical composition for oral administration free from the above problems including insufficiency in easiness to take the highly viscous liquid preparations and poor preservation stability of them.
On the other hand, it is not known so far that a medical preparation for oral administration is used in a jellied dosage form. Edible jellied compositions include sweet jellies used in food industry, which are prepared usually using as a base one or two or more of gelatin, pectin, xanthan gum, carrageenan, locust bean gum, mannnan, and the like. Their appearances are secured usually for about one year under preservation at room temperature or in a cool place. However, none of them can keep preservation stability in terms of pH and the contents of the effective components in addition to appearance at the medical level tests (for example, the preservation test at room temperature for three years, or an acceleration test at 40.degree. C. and 75% RH for six months).
As described above, there has been no case of using pharmaceutical preparations for oral administration in a jellied form as a dosage form that can be easily taken by patients of advanced age or patients with dysphagia. Further, at present, no base used for such a jellied pharmaceutical preparation for oral administration is available, which shows preservation stability in terms of maintenance of appearance and pH of the formulated jellied composition and maintenance of dispersibility and the contents of the effective components in the composition, stability of which is bearable to the medical level tests, such as a preservation test at room temperature for three years, or an acceleration test at 40.degree. C. and 75% RH for six months. In addition, there is no information about a disposable container having a shape that makes it possible to take such a jellied medical composition for oral administration with solidity appropriate for swallowing and with good texture, and to improve compliance.